It is important to understand that the input to a phase process group is the output from the previous phase group process. That is, the inputs that are going into the execution process group requires the use of the the documentation from the planning process group. Without a Project Management Plan, Quality Management Plan, Work Breakdown…[Read more]

Evaluating risk may not be as murky as it may first appear. The lectures does not go too deep into risk management, but after assessing the risks, there are methods to better quantify the risks involved. Performance measurement metrics could be used directly in evaluating FMECA scores when determining the likelihood of failure. Of course, there is…[Read more]

The team structuring of risk management is dependent on the risk, resources, and time restraints on the project.

As mentioned by jb678, the amount of risk involved in a project will determine the need for a separate risk management team. Risk management is a science, and so for a project with high risk, a specialized team in risk management would…[Read more]

In resolving failure, the first step to take is to define the scope of what can be modified. In our simulation, this is the verification protocol and the product components. The listed specifications could not be modified. Therefore, we are limited to resolve the failure within the scope of changing the product components used and testing…[Read more]

If I was placed in the Design Control process of a project, I would likely find preference in the putting together the Design Specification Document (DSD). This is where the meat of the engineering is. The DSD is the transitioning stage from planning to execution, and requires detailed consideration in the design of a successful project. Several…[Read more]

This question becomes tricky because these documents should be carefully reviewed to ensure the safety and effectiveness of the device. We would not want minor miscalculation to snowball into a much larger issues that can become detrimental to the whole organization. Therefore, care must be taken when approving any Design Control documentation.…[Read more]

From my experience working on projects, deciding on detailed specifications may seem to be the most daunting task, but becomes clear-cut the more you are familiar with the process. The most important factor when specifying ranges of specs is the limiting conditions involved in the design input. I work on designs for a Solar Car team, and when we…[Read more]

As Dr. Simon discussed in his lecture videos, the clearance of a Class II device can at times be as costly and timely as a Class III device. Certain Class II devices will require a investigational device exemption (IDE) to support the safety and effectiveness in the 510(k) application. An IDE must be approved by the FDA to perform clinical trials…[Read more]

While the enforcement of regulatory compliance maintains safety and effectiveness of medical devices, it stymies innovation in the medical marketplace. As ec52 discussed, the EU’s transition to implement new regulations on medical devices to heighten scrutiny on clinical trials and post-market compliance is transforming the medical industry on the…[Read more]

I am not currently working in industry, but a variant of matrix organization structure would provide a suitable working environment. Consider an organization that separates their company into different industries to achieve specific corporate objective. Each industry has different divisions, each with the standard departments (R&D, marketing,…[Read more]

The funding of a project is dependent on the corporate strategy. If a medical device corporation aims to improves preventative healthcare, the company will take on projects that align with prevent diseases. This can be screening technology or improvement to implants that may introduce disease complication. If the project fills a highly desirable…[Read more]

I believe that the 70/30 for success is completely justified. If anything, 70% interpersonal skills is too low. The most important thing in life is the relationships you foster. Your relationships define your network and the opportunities that are opened to you. A persons social growth translates directly over to their professional growth. If you…[Read more]